- area
means a space.
- batch
means a defined quantity of materials or product that undergo the same process(es) so that it can be expected to be homogeneous.
- blending
means the process of combining materials complying with the same specification to produce a homogeneous intermediate or active substance;
- bulk
means any product which has completed all processing stages up to, but not including, final packaging;
- campaign manufacture
means the manufacture of a series of batches of the same product in sequence in a given period of time followed by strict adherence to preestablished control measures before transfer to another product.
- classical fermentation
refers to processes that use microorganisms existing in nature or modified by conventional methods such as irradiation or chemical mutagenesis, to produce active substances used as starting materials.
- cross-contamination
means the contamination of a material or product with another material or product;
- in-process controls
means the checks performed during production in order to monitor and, if necessary, adjust the process to ensure that the intermediate or active substance conforms to the required specifications;
- intermediate
means a material produced during steps of the processing of an active substance that undergoes further molecular change or purification before it becomes an active substance;
- mother liquor
means the residual liquid which remains after the crystallisation or isolation processes;
- primary reference standard
means a substance that has been shown by an extensive set of analytical tests to be authentic material of high purity and that is obtained from an officially recognised source, or prepared by independent synthesis, or obtained from existing production material of high purity, or prepared by further purification of existing production material;
- qualification
means the process of demonstrating that entities, premises, equipment, utilities, systems or materials are suitable for the intended task and can deliver the expected outcomes;
- quality risk management
means a systematic process, applied both proactively and retrospectively, for the assessment, control, communication and review of risks to the quality of the active substance;
- quarantine
means the isolation -physically or by other effective means- of materials, intermediate or active substances whilst awaiting a decision on their release or refusal;
- raw material
means starting materials, reagents, and solvents intended for use in the production of intermediates or active substances;
- reference sample
means a sample of a batch of materials used in the manufacture of the active substances used as starting materials in veterinary medicinal products which is stored for the purpose of being analysed should the need arise during the shelf life of the batch concerned;
- reprocessing
means introducing an intermediate or active substance, including one that does not conform to standards or specifications, back into the manufacturing process and repeating a crystallisation step or other appropriate chemical or physical manipulation steps that are part of the established manufacturing process;
- reworking
means subjecting an intermediate or active substance that does not conform to standards or specifications to one or more processing steps that are different from the established manufacturing process to obtain acceptable quality intermediate or active substance;
- secondary reference standard
means a substance of established quality and purity, as shown by comparison to a primary reference standard, used as a reference standard for routine laboratory analysis;
- signed
means the record of the individual who performed a particular action or review.
- validation
means the process of demonstrating that a method or process is suitable for its intended use;